Amneal Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Crexont (carbidopa and levodopa) extended-release capsules to treat Parkinson’s disease (PD).
Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that contains both immediate-release (IR) granules and extended-release (ER) pellets.
The prescription drug is indicated for adults with PD caused by infection or inflammation of the brain, or PD-like symptoms due to carbon monoxide or manganese poisoning.
Its formulation and dosage strengths are different from Rytary (carbidopa and levodopa) extended-release capsules, approved by the US FDA in 2015, said the US drugmaker.
Amneal intends to start commercialising Crexont to patients in the US, form the next month.
Amneal co-CEOs Chirag and Chintu Patel said: “The approval of Crexont is a seminal moment in the treatment paradigm for Parkinson’s disease.
“The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations.
“Crexont’s innovative formulation provides a longer duration of “Good On” time with less frequent dosing compared to IR CD/LD.
“Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the US and soon internationally. We are committed to continuing to advance Parkinson’s research and development as a leader in the space.”
According to Amneal, existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily ‘Good On’ time, as the disease progresses.
The ‘Good On’ time is defined as ‘On’ time without troublesome dyskinesia, a movement disorder that often appears as uncontrolled shakes, tics, or tremors.
In the treatment of PD, oral CD/LD formulations need improvement such that they achieve more ‘Good On’ time with fewer daily doses.
In the RISE-PD clinical trial, Crexont formulation showed a statistically significant improvement of 0.5 hours of additional ‘Good On’ time per day compared to IR CD/LD.
A post-hoc analysis of the primary endpoint showed an additional 1.6 hours of ‘Good On’ time per dose of Crexont, compared to IR CD/LD.
Furthermore, Crexont showed a safety profile that is consistent with IR CD/LD, with the most common adverse reactions being nausea and anxiety.
